BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    M.D.L. S.R.L.

    Reg #: 3004749705 · FEI: 3004749705 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    M.D.L. S.R.L.
    Registration Number
    3004749705
    FEI Number
    3004749705
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Tavani 1/a
    City
    Delebio (So) Sondrio
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K160316

    Owner / Operator

    Firm Name
    M.D.L. S.r.l.
    Operator Number
    10047695
    Address
    Via Tavani 1/a
    City
    Delebio (So)
    State
    Sondrio
    Postal Code
    23014
    Country
    IT
    Correspondent
    Marcello Dell 'Oca

    US Agent

    Business Name
    Followell Compliance Consultants LLC
    Contact Name
    Valerie Followell
    Address
    8049 Tripp Avenue
    City
    Skokie
    State
    IL
    ZIP
    60076
    Country
    US
    Email
    [email protected]
    Phone
    847 4006187

    Products

    Device Name Product Code
    Device, Percutaneous, Biopsy MJG
    Biopsy Needle FCG
    Instrument, Biopsy KNW
    Guide, Needle, Surgical GDF
    Needle, Biopsy, Cardiovascular DWO
    Needle, Aspiration And Injection, Disposable GAA
    Cannula, Surgical, General & Plastic Surgery GEA

    Proprietary Names

    FASTCUT P Disposable needle XXGxYYYmm for soft tissue biopsy compatible automatic Promag Gun EASYLOCK Modified Menghini needle, XXGxYYYmm for aspirated cytohistological biopsy FAST-CUT E Disposable needle XXGYYYmm for soft tissue biopsy compatible with automatic Promag 2.2 gun INTRO Coaxial introducer needle XXG for needles XXG FASTCUTS Disposable needle XXGxYYYmm for soft tissue biopsy, compatible with automatic Sterylab Fastgun Gun PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium FASTCUTM Disposable needle XXGxYYYmm for soft tissue biopsy compatible with Magnum Gun Bard HANDCUT Disposable needle XXGxYYYmm for soft tissue biopsy with manual action PALIUM COAXIAL Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium with coaxial XXGxYYmm FAST-CUT E Disp. needle XXGxYYYmm for soft tissue biopsy compatible with automatic Promag 2.2. gun with coaxial XXGxYYmm THEMY Automatic needle XXGxYYYmm for soft tissue biopsy. Notch 20mm SEMICUT Semiautomatic guillotine needle XXGxYYYmm for soft tissues biopsy without removable Luer Palium Automatic reusable gun for soft tissue biopsy EASYCUT Semiautomatic needle XXGxYYYmm for cytohistological biopsy by aspiration as for Menghini modified MARKSLIM Not repositionable needle XXGxYYYmm for mammary nodules localization, slimline, single hook REPOMARK Repositionable needle, homertype XXGxYYYmm for mammary nodules localization, single hook MARK Not repositionable disposable needle XXGxYYYmm for mammary nodule localization with single hook AUTOMARK Semiautomatic not repositionable needle XXGxYYYmm for mammary nodules localization, single hook MARKX Not repositionable disposable needle XXGxYYYmm for mammary nodule localization with double hook PEN-BONE Dispos. bone marrow biopsy needle for iliac crest marrow aspiration, light version XXGxYY/ZZmm OSTEOJ Disposable bone marrow biopsy needle with extraction wire and safety XXGxYYYmm HARVEST Disposable biopsy needle for bone marrow transplantation with "T" handle XXGxYYYmm PRESSTO Needle for bone biopsy with internal catching system and ergonomic handle, XXGxYYYmm ILLY Disposable needle for iliac crest marrow aspiration, "T" handle XXGxYY/ZZmm PICKUP Needle for bone biopsy XXGxYYYmm with external catching system, wire extraction JAMBLU Bone marrow biopsy needle light version with extraction wire XXGxYYYmm Bone-HarvestOR - Autologous bone harvesting system Cell-HarvestOR - Multiradial selective harvesting system of autologous bone marrow CYTOCUT Disposable chiba needle XXGxYYYmm for aspirated cyto-histological biopsy PneumoDart Liposuction cannula LP25180111, LP0907119, LP1718123

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)